Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528223
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Research of the Application of Artificial Intelligence Model PANDA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Research of the Application of Artificial Intelligence Model PANDA A MultiCenter Prospective Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The research objective of this project is to conduct a large-scale and prospective real-world validation of the Pancreatic Cancer Screening Model PANDA which was developed based on deep learning and plain CT scans in previous studies This validation will be carried out across different scenarios at the First Affiliated Hospital of Zhejiang University leveraging clinical big data The goal is to verify the models role in suggesting and supplementing the diagnosis of PDAC in clinical practice thereby laying the groundwork for large-scale opportunistic screening of PDAC
Detailed Description:
This study focuses on potential cases of clinically missed PDAC It aims to evaluate the pancreatic cancer screening model PANDA based on deep learning and non-enhanced CT scans in a prospective real-world cohort from multiple clinical scenarios at the First Affiliated Hospital of Zhejiang University The study will track patients with negative imaging reports but positive PANDA model findings verifying their pathology through gold standard examinations to assess PANDAs efficacy It aims to validate the models utility applicability sensitivity and specificity
Based on these objectives the study will undertake the following
1 Utilize PANDAs output to categorize enrolled patients into nonPDAC PDAC and normal groups It will compare these results with imaging findings Patients identified as PANDA-positive for PDAC but without corresponding imaging evidence of pancreatic lesions or those with imaging suggesting pancreatic findings but lacking subsequent clinical intervention will be categorized for follow-up These patients will be recalled to the hospital for further examination and diagnosis at Zhejiang Universitys First Affiliated Hospital For PDAC-positive cases identified during secondary examinations standard clinical procedures such as MDT will be followed for confirmation of pathology Patients identified as PDAC-negative during secondary examinations will undergo extensive follow-up for up to two years to determine outcomes thus validating PANDAs sensitivity and specificity Patients identified by PANDA as nonPDAC-positive but lacking corresponding pancreatic findings in imaging will undergo a review by hepatobiliary pancreatic surgeons to confirm accuracy Those reported as normal by PANDA but with imaging suggesting pancreatic abnormalities will undergo secondary review by surgical experts to confirm or rule out false negatives by PANDA
2 For true positive PDAC cases identified by PANDA medical records will be collected tumor marker levels patient symptoms resectability grading TNM staging etc for comparison with corresponding indicators from PDAC patients identified through the Standard Order of Clinic SOC This aims to validate PANDAs capability in early detection and identification of lesions in pancreatic cancer development
Based on these objectives the study will undertake the following
1 Utilize PANDAs output to categorize enrolled patients into nonPDAC PDAC and normal groups It will compare these results with imaging findings Patients identified as PANDA-positive for PDAC but without corresponding imaging evidence of pancreatic lesions or those with imaging suggesting pancreatic findings but lacking subsequent clinical intervention will be categorized for follow-up These patients will be recalled to the hospital for further examination and diagnosis at Zhejiang Universitys First Affiliated Hospital For PDAC-positive cases identified during secondary examinations standard clinical procedures such as MDT will be followed for confirmation of pathology Patients identified as PDAC-negative during secondary examinations will undergo extensive follow-up for up to two years to determine outcomes thus validating PANDAs sensitivity and specificity Patients identified by PANDA as nonPDAC-positive but lacking corresponding pancreatic findings in imaging will undergo a review by hepatobiliary pancreatic surgeons to confirm accuracy Those reported as normal by PANDA but with imaging suggesting pancreatic abnormalities will undergo secondary review by surgical experts to confirm or rule out false negatives by PANDA
2 For true positive PDAC cases identified by PANDA medical records will be collected tumor marker levels patient symptoms resectability grading TNM staging etc for comparison with corresponding indicators from PDAC patients identified through the Standard Order of Clinic SOC This aims to validate PANDAs capability in early detection and identification of lesions in pancreatic cancer development
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None